A Novel Mechanics-based Intervention to Improve Post-stroke Stability

NCT02964039 | Completed Results DMC

• 2 other identifiers: N2256-RRX002256
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether a novel treadmill training intervention can improve the gait stabilization strategy used by individuals who have experienced a stroke.

Conditions

Stroke

Keywords

stroke; rehabilitation; gait

Outcome Measures

Primary Outcomes (1)

• Partial Correlation Between Pelvis Displacement and Paretic Step Width During Gait (Change From Baseline)

  A custom measure that quantifies the strength of the relationship between body mechanics and foot placement. This measure falls within a relatively narrow range among neurologically intact controls, but is substantially reduced in some individuals who have experienced a stroke, indicating a reduced ability to stabilize their gait pattern. This measure relates the mechanical state of the body at the start of each step (mediolateral pelvis displacement and velocity of the pelvis relative to the stance foot) to the step width at the end of the step. Specifically, the partial linear correlation between pelvis displacement and step width was calculated, accounting for variation in pelvis velocity. The change in this measure relative to baseline is calculated at four time points (after 4, 8, 12, and 24 weeks).

  baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

Secondary Outcomes (5)

• Functional Gait Assessment (Change From Baseline)

  baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

• Activities-specific Balance Confidence Scale (Change From Baseline)

  baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

• 10-meter Walk Test (Change From Baseline)

  baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks

• Fall Incidence

  6 months (during 12 week follow-up period)

• Fear of Falling

  6 months (at completion of 12-week Follow-up period)

Study Arms (3)

Error reduction

EXPERIMENTAL

Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error reduction" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.

Behavioral: Error reduction

Error augmentation

EXPERIMENTAL

Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "error augmentation" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.

Behavioral: Error augmentation

Activity matched control

SHAM COMPARATOR

Participants will complete a 12-week training program, in which they practice walking on a treadmill for 30-minutes during twice-weekly training sessions. During these sessions, participants will interface with a custom-built force-field able to exert mediolateral forces on the legs, which will be in "transparent" mode. This training period will be followed by a 12-week follow-up period. Five assessment sessions will be interspersed throughout this total 24-week period.

Behavioral: Activity matched control

Interventions

Error reduction BEHAVIORAL

During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.

Error reduction

Error augmentation BEHAVIORAL

During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.

Error augmentation

Activity matched control BEHAVIORAL

During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.

Activity matched control

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 21 years old
• Experience of a stroke 6 months prior to participation
• Preferred overground gait speed of at least 0.2 m/s
• Ability to walk at self-selected speed for 3 minutes without a cane or walker
• Provision of informed consent.

You may not qualify if:

• Resting heart rate above 110 beats/min
• Resting blood pressure higher than 200/110 mm Hg
• History of congestive heart failure, unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living
• Preexisting neurological disorders or dementia
• History of major head trauma
• Legal blindness or severe visual impairment
• Life expectancy \<1 yr; 8)
• History of deep vein thrombosis or pulmonary embolism within 6 months
• Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions
• Orthopedic injuries or conditions (e.g. joint replacements) in the lower extremities with the potential to alter the gait pattern.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The overall dropout rate of this study was increased by the research shutdown with the coronavirus pandemic.

Results Point of Contact

• Title: Jesse Dean
• Organization: Ralph H. Johnson VAMC / MUSC

deaje@musc.edu

8437929566

Study Officials

• Jesse C. Dean, PhD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2016
• First Posted: November 15, 2016
• Study Start: April 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: June 3, 2024
• Results First Posted: July 28, 2021

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)